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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,6,8-Pyrenetetrasulfonic acid, sodium salt
EC Number:
626-424-1
Cas Number:
59572-10-0
Molecular formula:
C16H16O12S4.4Na
IUPAC Name:
1,3,6,8-Pyrenetetrasulfonic acid, sodium salt

In vitro test system

Test system:
human skin model
Source species:
other: the human epidermis
Cell type:
non-transformed keratinocytes
Vehicle:
other: Dulbecco’s phosphate buffered saline (DPBS)
Details on test system:
The test system (non-transformed human-derived epidermal keratinocytes cultured to form a complex model of the human epidermis) was validated and approved by regulatory authorities for evaluation of skin irritation potential. The EpiDerm™ SIT was developed and designed to predict skin irritation potential of neat test substances in the context of identification and classification of skin irritation hazard according to the EU classification system (R 38 or no label).
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
44 hours+3 hours
Number of replicates:
9

Test animals

Species:
other: human-derived epidermal keratinocytes

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
60 minutes
Number of animals:
9

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
PTSA
Value:
93.7
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
other: PTSA meets the requirement for UN GHS Category: No Category.
Conclusions:
Under the conditions of this study, PTSA is considered a non-irritant.